FDA Submission Date definition

FDA Submission Date means the date that the SGN-CD33A BLA is submitted to the FDA.
FDA Submission Date means the earlier of (i) the date that the EV BLA is submitted to the FDA and (ii) the date that the TV BLA is submitted to the FDA.
FDA Submission Date means the date on which the Tucatinib NDA is submitted to the FDA. 182894448 v14

Examples of FDA Submission Date in a sentence

  • If a Participant is below the Associate Director level on the FDA Submission Date, the amount of cash subject to the TV Portion of such Participant’s Cash Award shall be equal to: 100% of the Target Award Value applicable to such Participant, multiplied by the TV Percentage, multiplied by the applicable earn out percentage in the Payout Matrix.

  • If a Participant is at the Associate Director level or above on the FDA Submission Date, the number of shares of Common Stock subject to the TV Portion of such Participant’s Stock Award shall be equal to: (50% of the Target Award Value applicable to such Participant, multiplied by the TV Percentage, multiplied by the applicable earn out percentage in the Payout Matrix) divided by the closing sales price of the Common Stock on the date of grant of such TV Portion.

  • Absent any determination by the Committee to the contrary, each Employee who is newly hired after March 31, 2010 and before the FDA Submission Date and qualifies as an Eligible Employee shall automatically be deemed a Participant and shall be eligible to participate in the Plan for the portion of the period beginning with such individual’s first day of employment until the FDA Submission Date.

  • In addition, except with respect to Stock Awards granted under the Plan to a Participant who is a Covered Employee, prior to the determination of Actual Award Values, the Committee may otherwise increase the Target Award Value of any Participant to reflect a change in the Participant’s responsibility level or position prior to the FDA Submission Date.

  • Except with respect to Stock Awards granted under the Plan to a Participant who is a Covered Employee, if a Participant is promoted after March 31, 2010, but prior to the FDA Submission Date to a position with higher Target Award Value(s), then such Participant’s Target Award Values shall be increased by a prorated amount (based on the effective date of such individual’s promotion through the FDA Submission Date).

  • Subject to Sections 4(b) and 4(c) of the Plan, the Target Award Value applicable to a Participant shall be the Target Award Value contained in the Target Award Value Table for the Participant’s job level tier as of the FDA Submission Date.


More Definitions of FDA Submission Date

FDA Submission Date means the date that the Company submits the Brentuximab Vedotin NDA with the FDA.

Related to FDA Submission Date

  • Bid Submission Date means the last date by which the City will accept Bids for an Invitation For Bid.

  • Submission Date means the date on which You Submit a Contribution to Us.

  • Submission Deadline means 1:00 P.M., New York City time, on any Auction Date or such other time on any Auction Date as may be specified by the Auction Agent from time to time as the time by which each Broker-Dealer must submit to the Auction Agent in writing all Orders obtained by it for the Auction to be conducted on such Auction Date.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • Bid Submission Requirement means a task a Prospective Contractor must complete when submitting a bid response. These requirements will be distinguished by using the term “shall” or “must” in the requirement.

  • Admission Date has the meaning set forth in Section 10.06.

  • Target Completion Date has the meaning given such term in Section 3.3(b).

  • Notification Date means 30 days from an Account statement date (see section 6.3).

  • Extension Determination Date means, in respect of a Series of Covered Bonds, the date falling two Business Days after the expiry of seven days from (and including) the Final Maturity Date of such Covered Bonds.

  • Publication Date means an Ordinary Publication Date or an Extraordinary Publication Date, as the case may be.

  • Delivery Period Termination Date Has the meaning specified in the Related Pass Through Trust Supplement.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • continuing candidate means any candidate not deemed to be elected, and not excluded,

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.

  • Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Project Completion Date means the date on which the Completion Certificate is issued;

  • Non-Acceptance of Proposal means another proposal was deemed more advantageous to the University or that all proposals were rejected.

  • Study Period means the period commencing at 9:00 a.m. on the date hereof, and continuing through 5:00 p.m. on the Closing Date.

  • Mitigation Study Period means the duration of time extending six consecutive Capability Periods and beginning with the Starting Capability Period associated with a Class Year Study, Additional SDU Study, and/or Expedited Deliverability Study. For purposes of Section 23.4.5 of this Attachment H, “Mitigated UCAP” shall mean one or more megawatts of Unforced Capacity that are subject to Control by a Market Party that has been identified by the ISO as a Pivotal Supplier. For purposes of Section 23.4.5 of this Attachment H, “Mitigation Net CONE” shall mean the capacity price on the currently effective ICAP Demand Curve for the Mitigated Capacity Zone corresponding to the average amount of excess capacity above the Mitigated Capacity Zone Installed Capacity requirement, expressed as a percentage of that requirement, that formed the basis for the ICAP Demand Curve approved by the Commission.

  • Evaluation Date shall have the meaning ascribed to such term in Section 3.1(s).

  • major non-compliance outcome notification means a notification received by a council under section 19N(3) or (4) of the Food Act 1984, or advice given to council by an authorized officer under that Act, of a deficiency that does not pose an immediate serious threat to public health but may do so if no remedial action is taken

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.

  • Evaluation Period bears the meaning ascribed thereto in Section 7.4(d)(i);

  • Commissioning Period means, with respect to each Subproject, the period commencing upon the first delivery of Feed Gas to the Subproject in accordance with Sections 4.8 and 11.1 of the Agreement continuing through achievement of RFSU, commissioning, Start Up, Performance Testing and achievement of Substantial Completion for such Subproject.

  • Discussion Time shall have the meaning ascribed to such term in Section 3.2(f).

  • Section 385 Expanded Group shall have the meaning set forth in Treasury Regulation Section 1.385-1(c)(4) for an “expanded group”.